Impact of Pulse-enriched Foods on Cognitive Function and Cardiometabolic Health in Obese Adults

NCT01495832 | Completed

• 1 other identifier: B2001:084
• Study Type: interventional
• Target: 150
• Locations: 2 countries
• Sites: 2

Brief Summary

The Canadian population, as is the case in most developed countries, is ageing and becoming increasingly overweight and/or obese. Both ageing and obesity are associated with reduced cognitive performance which can impact adversely on the ability to undertake daily activities and increases the risk of loss of independent living and reduced quality of life. The investigators predict that consumption of ½ cup of pulses per day for 12 weeks will improve cognitive function in older overweight/obese adults and thus decrease the rate of cognitive decline that occurs in this at-risk population.

Conditions

Obesity

Keywords

Adult Obesity; Cardiometabolic health; Pulse Foods; Beans, Peas, Lentils; Cognitive Function

Outcome Measures

Primary Outcomes (2)

• Vascular Function

  Vascular function will be assessed non-invasively (at baseline, Week 6, and Week 12) with measurement of arterial compliance (elasticity) by pulse wave analysis and pulse wave velocity. Measurement of arterial vasodilation will be done non-invasively to evaluate endothelial cells which line the blood vessels that regulate blood flow. Blood samples will be taken to assess markers of vascular function.

  12 weeks

• Cerebral Blood Flow Velocity (Australian Site only)

  Cerebral blood flow velocity will be assessed (baseline , Week 6, Week 12) by transcranial Doppler ultrasonography. This will serve as an index of arterial vasodilator responsiveness in the cerebral circulation. This will be performed by the Australian site only.

  12 Weeks

Secondary Outcomes (1)

• Cognitive Function

  12 weeks

Study Arms (2)

Pulse Group

EXPERIMENTAL

The pulse group will consume pulse-enriched foods designed to deliver ½ cup of pulses per day for 12 weeks.

Other: Pulse Group

Control Group

ACTIVE COMPARATOR

The control group will consume comparator foods for 12 weeks.

Other: Control Group

Interventions

Pulse Group OTHER

The pulse group will consume pulse-enriched foods designed to deliver ½ cup of pulses per day for 12 weeks.

Also known as: Sanitarium, Heinz, Simplot

Pulse Group

Control Group OTHER

The control group will consume comparator foods for 12 weeks.

Control Group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or females, between 50-80 years of age
• Body Mass Index (BMI) of \>25 kg/m2
• Must be on a stable regime for the past 6 months if taking medications or supplements for elevated lipids, blood pressure, glucose management, mood, pain, or insomnia
• Consume 1 or less servings of pulses per week
• Able to read and understand English
• Willing to comply with the protocol requirements
• Willing to provide informed consent.

You may not qualify if:

• Body weight ≥135 kg (since this exceeds the capability for Dual Energy X-ray Absorptiometry, i.e, DEXA scanning to assess body composition)
• Established cardiovascular, liver, or kidney disease
• Uncontrolled diabetes (hemoglobin HbA1c \>8)
• A score of ≤23 on the Mini Mental State Examination
• Use of appetite suppressants or Orlistat (Xenical)
• Inability to consume pulse-enriched foods (i.e., beans, peas, chickpeas, and lentils) due to allergies or severe gastrointestinal reactions
• Pregnancy
• Smoking or only recently quit smoking (smoked any cigarettes within the last 12 months)
• Weight loss of ≥3kg of body weight within the 6 months prior to enrolling in the study
• Adherence to a weight loss diet or physical activity program designed to facilitate weight loss
• Acute or terminal illness.

Sponsors & Collaborators

• University of Manitoba: lead
• University of South Australia: collaborator

Study Sites (2)

University of South Australia, Nutritional Psysiology Research Centre, Sansom Institute for Health

Adelaide, South Australia, 5001, Australia

Location

St. Boniface Hospital Research Centre

Winnipeg, Manitoba, R2H 2A6, Canada

Location

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Related Links

• St. Boniface General Hospital Research Centre
• Canadian Centre for Agri-food Research in Health \& Medicine

MeSH Terms

Conditions

Obesity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Peter Zahradka, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Physiology

Study Record Dates

• First Submitted: December 16, 2011
• First Posted: December 20, 2011
• Study Start: June 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: September 25, 2014

Record last verified: 2014-09

Locations

AU (1); CA (1)